Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, Landy H, Eengrand P, Shah S
Division of Endocrinology and Metabolism, University of Virginia Health Sciences Center, Charlottesville 22908, USA.
J Clin Endocrinol Metab. 1996 Mar;81(3):1189-96. doi: 10.1210/jcem.81.3.8772599.
The efficacy and safety of 1 yr of GH-releasing hormone [GHRH-(1-29)] therapy in GH-deficient children were determined. One hundred and ten previously untreated prepubertal GH-deficient children were treated for up to 1 yr in a multicenter, open label study with 30 micrograms/kg GHRH-(1-29)/day, sc, given at bedtime. Eighty-six of the 110 patients were eligible for efficacy analysis. The main outcome measures, monitored every 3-6 months, were linear growth enhancement (height velocity), bone age progression, and safety measures including clinical chemistry. The mean height velocity for the group increased from 4.1 +/- 0.9 cm/yr at baseline to 8.0 +/- 1.5 and 7.2 +/- 1.3 cm/yr after 6 and 12 months of therapy, respectively. At 6 months, 74% of the children were considered to have a good response to GHRH. The ratio of the change in bone age to height age was not significantly different from unity at 12 months (1.04 +/- 0.58; P = 0.63). No adverse changes in general biochemical or hormonal analyses were noted. No change in fasting glucose concentration or excessive generation of insulin-like growth factor I occurred, and overall GHRH was well tolerated. We conclude that GHRH administered as a once daily dose of 30 micrograms/kg GHRH.(1-29), s.c., was effective in increasing height velocity in GH-deficient children.
确定了生长激素释放激素[GHRH-(1-29)]治疗1年对生长激素缺乏儿童的疗效和安全性。在一项多中心、开放标签研究中,110名未经治疗的青春期前生长激素缺乏儿童接受了长达1年的治疗,皮下注射剂量为30微克/千克GHRH-(1-29)/天,于睡前给药。110名患者中有86名符合疗效分析条件。每3至6个月监测的主要结局指标为线性生长加速(身高速度)、骨龄进展以及包括临床化学在内的安全性指标。该组的平均身高速度从基线时的4.1±0.9厘米/年分别增至治疗6个月和12个月后的8.0±1.5厘米/年和7.2±1.3厘米/年。6个月时,74%的儿童被认为对GHRH反应良好。12个月时,骨龄变化与身高年龄的比值与1无显著差异(1.04±0.58;P = 0.63)。未观察到一般生化或激素分析有不良变化。空腹血糖浓度未改变,也未出现胰岛素样生长因子I过度生成的情况,总体而言,GHRH耐受性良好。我们得出结论,以每日一次、皮下注射剂量为30微克/千克GHRH.(1-29)给药,对增加生长激素缺乏儿童的身高速度有效。